Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Preventing Depression Recurrence in Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374426
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
To study the effectiveness of sertraline (Zoloft) in treating depression in adults with diabetes. The study will also determine whether depressed diabetic patients who have successfully responded to sertraline (Zoloft) are more likely to have depression recur if the sertraline (Zoloft) is discontinued.

Condition or disease Intervention/treatment Phase
Major Depression Diabetes Drug: sertraline Phase 4

Detailed Description:

Part A: Prevention of Depression Recurrence in Diabetes

  1. To determine the efficacy of maintenance antidepressant medication in preventing or delaying recur-rence of major depression in diabetes.
  2. To determine the relationship of sustained depression remission to social, occupational, and global func-tioning, and to quality of life and compliance with diabetes treatment.
  3. To determine clinical features predictive of depression recurrence in diabetes.

Part B. Longitudinal Study of the Interrelationship of Glycemic Control and Depression

  1. To determine the effects of depression remission and recurrence on glycemic control.
  2. To determine the efficacy of maintenance antidepressant medication in producing sustained benefits in glycemic control.
  3. To determine the interrelationship of daily mood with blood glucose and the effect of maintenance treatment on this relationship.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Preventing Depression Recurrence in Diabetes
Study Start Date : March 1998
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-80
  • Type 1 or Type 2 Diabetes
  • Screen positive for depression

Exclusion Criteria:

  • Are pregnant or lactating
  • Are known to be hypersensitive to the drug
  • Have a recent history of myocardial infarction or unstable heart disease
  • Have severe hepatic disease or renal impairment (serum creatinine > 3 mg/dl)
  • The subset of patients with psychiatric disorders thought to affect management (e.g., schizophrenia, alcohol and drug dependence) will also be excluded from participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374426


Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Patrick J Lustman, Ph.D. Washington University School of Medicine

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00374426     History of Changes
Other Study ID Numbers: 96-0806 (completed)
DK53060
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
depression
diabetes mellitus
depression recurrence

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Diabetes Mellitus
Recurrence
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs